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FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyep...[ Price : $8.95]
Saol Therapeutics refiles its NDA for SL1009 (sodium dichloroacetate), an investigational treatment for pyruvate dehydrogenase com...[ Price : $8.95]
FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will co...[ Price : $8.95]
Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party la...[ Price : $8.95]
During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no l...[ Price : $8.95]
FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven pep...[ Price : $8.95]
Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could chan...[ Price : $8.95]
FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in r...